dcsimg FDA Regulatory - Life Sciences

Life Sciences - FDA Regulatory

McGuireWoods’ Life Science – Food and Drug Administration (FDA) Regulatory Industry Team provides strategic guidance to life science companies involved in the manufacture and distribution of pharmaceuticals, biologics, and medical devices. Our mission is to solve problems efficiently, add value and implement strategies that help clients achieve their ultimate goals.

McGuireWoods believes that a holistic, multidisciplinary approach to health sciences products is the only way to effectively navigate your business. Thus, we have created a team of regulatory, policy counsel, and strategic compliance consulting professionals. We partner with clients from emerging-growth companies to large pharmaceutical, biotechnology, medical device companies, and academic institutions to develop, implement, and monitor regulatory programs from product development through launch, commercialization, and quality management. Our goal is to become an integral and efficient component of your business.

Regulatory Guidance

Our lawyers provide pharmaceutical and medical device manufacturers and other health science companies with strategic regulatory guidance and preventative liability consulting. At whatever stage of your business, we can analyze your compliance strategy, prepare and file FDA submissions, provide benchmarking audit and analysis of your regulatory and liability postures, establish and monitor applicable internal compliance programs, and take you through implementation. In addition to drafting or reviewing documents required to obtain approval of new products, we guide our clients in the highly scrutinized area of product promotion, often reviewing advertising and marketing initiatives for FDA and Federal Trade Commission (FTC) compliance. We also draw on the resources of our full-service public affairs subsidiary, McGuireWoods Consulting, to provide strategic communications and government relations services.

We stay abreast of changes to regulatory policy and procedure–especially in this new era of heightened regulation and enforcement. We likewise monitor the product liability landscape because, in the current climate, litigation prevention counseling can be your soundest business investment. Should claims arise, we believe that preventative measures are the most solid foundation on which to build a legal defense.

Compliance

With respect to day-to-day FDA compliance, we assist clients with developing standard operating procedures (SOPs) to comply with FDA directives and current Good Manufacturing Practices (cGMP), quality system regulation (QSR) and inspections, as well as compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We analyze client compliance positions against FDA regulatory requirements and policies. We also assist clients with understanding their current compliance positions, and develop regulatory solutions that meet both their compliance requirements and business needs.

Litigation

Litigation prevention is a valuable business investment in today’s market, and we regularly advise clients on risk-management and litigation-avoidance strategies. When business disputes, government investigations or law enforcement actions arise, our team provides a strong defense at every stage of pre-trial, trial and appellate processes. We have defended individuals and companies in various types of FDA-related litigation, including grand jury investigations, criminal prosecutions, and civil regulatory and enforcement matters in federal and state courts. Among other matters, we have represented companies in numerous seizure and injunction actions.

International

We have exclusive consulting agreements with former FDA managers, connections with contact research organizations, and myriad contract experts in science and technology. We also have a premiere international presence. Through our own worldwide offices and international affiliates, we can provide the highest caliber regulatory services for life science companies in most countries around the world.

CONTACTS

Brian J. Malkin Senior Counsel T: +1 202 857 1704
Stephanie A. Kennan Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC T: +1 202 857 2922

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FDA Life

Results 1-6 of 6

RESULTS DEPEND ON A VARIETY OF FACTORS UNIQUE TO EACH CASE. PRIOR RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR OUTCOME.

Representative Matter

Biosimilar manufacturer

Assisted biosimilar manufacturer with developing clinical trial strategies for approval, which included considering biosimilar approvals in other countries, such as possible 505(b)(2) NDA approval strategies.
Representative Matter

Generic drug manufacturer

Assisted generic drug manufacturer in abbreviated new drug application (ANDA) patent litigation related to advertising and promotion material for marketed products, including reviews by the Division of Prescription Drug Promotion (OPDP) with regard to the listing or assertion of method-of-use patents.
Representative Matter

Medical device manufacturer

Provide assistance to medical device manufacturer with determining appropriate classification for their proposed devices, including assisting with their 510(k) clearances and premarket approval applications (PMAs).
Representative Matter

Generic drug manufacturer

Assisted generic drug manufacturer with obtaining samples for products and develop shared or separate risk evaluation and mitigation strategies (REMS)

Representative Matter

Generic drug manufacturer

Provide assistance to a generic drug manufacturer with developing strategy for administrative proceedings including filing or responding to citizen petitions and challenging FDA review decision prior to filing legal action against the FDA.
Representative Matter

Major pharmaceutical manufacturer

Assisted major pharmaceutical manufacturer in developing clinical strategy and participating in FDA meetings to obtain new approval.
Results 1-6 of 6
Results 1-25 of 31
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Mark E Anderson Mark E. Anderson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 919 755 6678
F: +1 919 755 6581
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George J Barry III George J. Barry III
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5734
F: +1 404 443 5753
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Scott Becker Scott Becker
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 6016
F: +1 312 920 6135
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Micheal L Binns Micheal L. Binns
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5748
F: +1 404 443 5698
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Ginny Boland Ginny Boland
Asst. VP, Strategic Communications McGuireWoods Consulting LLC
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1907
F: +1 804 775 1061
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Bryan C Brantley Bryan C. Brantley
Partner
EQT Plaza
625 Liberty Avenue
23rd Floor
Pittsburgh, PA 15222-3142

T: +1 412 667 7983
F: +1 412 667 7971
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Brie Buchanan Brie L.B. Buchanan
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5709
F: +1 404 443 5760
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William Bushman William G. Bushman
Associate
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1806
F: +1 804 775 1061
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Karen L Carroll Karen L. Carroll
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5620
F: +1 404 443 5757
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Joan S Dinsmore Joan S. Dinsmore
Associate
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

T: +1 919 755 6693
F: +1 919 755 6592
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Kathleen H Dooley Kathleen H. Dooley
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2347
F: +1 704 444 8755
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Christina M Egan Christina M. Egan
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8644
F: +1 312 698 4502
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Christopher K Greene Christopher K. Greene
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5721
F: +1 404 443 5692
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Matthew Hall Matthew Hall
Partner
rue des Colonies 56 - box 3
1000 Brussels

T: +32 2 629 42 34
F: +32 2 629 42 22
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Jessica Hauth Jessica M. Hauth
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5743
F: +1 404 443 5775
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Steven J Keeler Steven J. Keeler
Partner
Court Square Building
310 Fourth Street, N.E.
Suite 300
Charlottesville, VA 22902-1288

1750 Tysons Boulevard
Suite 1800
Tysons Corner, VA 22102-4215

T: +1 434 977 2512
F: +1 434 980 2259
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T:+1 703 712 5138
F: +1 434 980 2259

Nathan A Kottkamp Nathan A. Kottkamp
Partner
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1092
F: +1 804 698 2072
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Timothy H Kratz Timothy H. Kratz
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5730
F: +1 404 443 5784
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Brian J. Looser
Asst. VP, Federal Public Affairs McGuireWoods Consulting LLC
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 2919
F: +1 202 828 2985
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Brian Malkin Brian J. Malkin
Senior Counsel
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

7 Saint Paul Street
Suite 1000
Baltimore, MD 21202-1671

T: +1 202 857 1704
F: +1 202 828 2964
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T:+1 202 857 1704
F: +1 202 828 2964

Patrick G. Martin
Asst. VP, Federal Public Affairs McGuireWoods Consulting LLC
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 1700
F: +1 202 828 3326
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Chris McEachran Christopher D. McEachran
Associate
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 1722
F: +1 202 828 2986
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Yves Melin Yves Melin
Partner
rue des Colonies 56 - box 3
1000 Brussels

T: +32 2 629 42 26
F: +32 2 629 42 22
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Raj Natarajan Raj Natarajan
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2330
F: +1 704 353 6147
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Stephen Older Stephen Edward Older
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 212 548 2122
F: +1 212 715 2307
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Results 1-20 of 20
Event

6th Annual Medical Device and Life Sciences Conference

Tuesday, November 18, 2014
Chicago, IL
Speaking Engagement

Europe v. U.S. Food, Drug, Device & Tobacco Regulation & Policy

Emerging Issues and Comparative Analysis

Friday, November 14, 2014
Brussels
Belgium
Speaking Engagement

AdvaMed 2014: The MedTech Conference

October 7, 2014
Chicago, IL
Speaking Engagement

Redefining Early Stage Investments

The Case for Small Markets with Large Returns: Orphans/Rare Disease Panel

September 17, 2014
Boston, MA
Speaking Engagement

Legal and Regulatory Summit on Generic Drugs

July 24-25, 2014
New York, NY
Speaking Engagement

5th Annual Conference on Biosimilars

June 4-6, 2014
New York, NY
Speaking Engagement

2014 Food and Drug Law Institute Annual Conference

Breakfast Break-out: Career Opportunities in Food & Drug Law

April 24, 2014
Speaking Engagement

BioCentury This Week

Safety v. Competition (Federal Trade Commission Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition February 4, 2014 Overview)

February 16, 2014
Speaking Engagement

Montgomery County Department of Economic Development

Biotechnology Roundtable: Innovative Strategies for New Product Development

February 5, 2014
Speaking Engagement

New York State Bar Association's Annual Meeting of the Food, Drug and Cosmetic Law Section

FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation – Perspectives from Two Former FDA Officials

January 30, 2014
Speaking Engagement

ExL Pharma's 6th Risk Evaluation and Mitigation Strategies Summit

Understand the FDA Report [Risk Evaluation and Mitigation Strategies ("REMS") Standardization] and the Impact on the Industry

January 28, 2014
Speaking Engagement

Korea-Maryland USA Bio Expo

Current Good Manufacturing Practice (cGMP) and its Role in Regulatory Drug Quality", "Current Drug Shortages and Orphan Drug Disease Pharmaceutical Development", and "Innovative Strategies for New Drug Development/Biobetters

November 8, 2013
Speaking Engagement

Clinical Data Management Innovation Conference

Update on FDA’s Draft Guidance for Electronic Source Data in Clinical Investigations

October 29, 2013
Speaking Engagement

Public Meeting, Standardizing and Evaluating Risk Evaluation and Mitigation Strategies

Standardizing Shared REMS

July 25, 2013
Speaking Engagement

Global Clinical Risk Management & Regulatory Policy Conference

Developing a Single, Shared REMS in a Collaborative Setting

July 11, 2013
Speaking Engagement

Food and Drug Law Institute Annual Conference

Center for Biologics Evaluation and Research Breakout Session

April 24, 2013
Speaking Engagement

New York State Bar Association, Food, Drug and Cosmetic Law Section

Pivotal Cases for FDA Practitioner: 2012-2013 Updates” and “In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice

January 24, 2013
Speaking Engagement

Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process

Mastering the Intricacies of the Orphan Drug Designation Process: A Step-by-Step Guide to Navigating the Pathway

November 29, 2012
Speaking Engagement

Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars

Preparing for the Evolution of the Generic Drug and Biosimilars Industry" and "Biobetters and Extending into the Marketplace Beyond Patent Expiration

July 12, 2012
Results 1-20 of 20
Results 1-17 of 17
Legal Alert

FDA’s Recent Two-Pronged Attack on Drug Shortages

Four Things to Know about FDA’s Proposed Rule

December 11, 2013
Legal Alert

Drug Quality and Security Act

What You Need to Know

December 4, 2013
Article

Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?

Navigating Recent Off-Label Promotion Developments, Understanding Government Relations and the Potential Impact of Noteworthy Cases

(Aspatore Special Report)
September 1, 2013
Brian J. Malkin, Aspatore/Thompson Reuters
Legal Alert

FDA Seeks to Tighten Drug Import Regulation

August 9, 2013
Legal Alert

FDA Attempts To Secure The Border

Proposed FSMA Rules Aim To Even Playing Field Between Domestic And Foreign Food Suppliers

August 6, 2013
Legal Alert

New FDA Guidance on Medical Devices

Enhanced Reporting Requirements for Adverse Events

August 1, 2013
Article

The Drug/Biologics Approval Process: An FDLI Primer

Food and Drug Law Institute Update Magazine
January 2013
Article

Challenges to the Development of a Biosimilars Industry in the United States

Aspatore/Thompson Reuters Recent Developments in Food and Drug Law (2013 Edition)
December 3, 2012
Results 1-17 of 17